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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual

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 Class 2 Device Recall Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dualsee related information
Date Initiated by FirmAugust 21, 2012
Date PostedSeptember 25, 2012
Recall Status1 Terminated 3 on December 24, 2013
Recall NumberZ-2451-2012
Recall Event ID 63044
510(K)NumberK012009 K013521 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductComputed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
Code Information System Code #: 728130; Serial #: 8128, 8158 & 8369.  System Code #: 728256; Serial #: 3695, 3703, 371 &, 3719.  System Code #: 728246; Serial #: 3463, 3508, 3519, 3548, 3552, 3591, 3592, 3593, 3603, 3637, 3648, 3654, 3659, 3661, 3675, 3679, 3687, 3692, 5451, 5515, 5543, 5567, 5583, 5586, 5658, 5664, 5675, 5697, 5707, 5749, 5752, 5774, 5807, 5813, 5815, 5845, 5846, 5852, 5866, 5872, 5910, 5963, 5968, 6028, 6036, 6045, 6071 & 6126.  System Code #: 882160; Serial #: 97, 102, 103, 105, 106, 107, 109, 110, 111, 113, 114, 115, 116, 117, 118, 121, 122, 123, 124, 125, 126, 127, 131, 132, 133, 134, 135, 136, 137, 139, 140, 141, 143, 144, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162

63, 164, 165, 167, 1065 & 6119.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information ContactJoseph Vinhais
440-483-7000
Manufacturer Reason
for Recall		A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionPhilips Healthcare sent an Urgent Medical Device Correction letter dated August 22, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that no action needed to be taken at that time b the customer or user. A Philips Field Service Engineer would schule a time to inspect and repair all the affected systems within approximately 6 months. For further information customers were instructed to contact their local Philips representative or contact the Philips Healthcare Customer Care Solution Center at 1-800-722-9377 and follow the recorded menu options toreach a Customer Solutions Engineer. For questions regarding this recall call 440-483-7000.
Quantity in Commerce112 Units
DistributionWorldwide Distribution - USA including AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Jordan, Mexico, Saudi Arabia, South Korea, Spain, Thailand, Turkey & United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAK
510(K)s with Product Code = JAK
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